Information Collection

Recall Communications-third party disclosure (including Agency Guidance recommendations)

IC 215023 under ICR 202403-0910-012 · OMB 0910-0249.

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IC Title:

Recall Communications-third party disclosure (including Agency Guidance recommendations)

Agency IC Tracking Number:

ORA

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 7.49

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 2,309

Number of Respondents for Small Entity: 200

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 95 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	2,558,372	1,321,717	1,236,655
Annual IC Time Burden (Hours)	127,919	66,086	61,833
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.